Research Regulatory Specialist jobs in United States
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Mass General Brigham · 4 months ago

Research Regulatory Specialist

positionBoston-MA
timeFull-time
remoteHybrid
seniorityMid Level
money$62K/yr - $91K/yr

Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. The Research Regulatory Specialist is responsible for ensuring regulatory compliance for clinical research studies, including preparing and submitting regulatory documentation and guiding investigators through the IRB review process.

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H1B Sponsor Likelynote

Responsibilities

The preparation and submission of protocols to the IRB
Assists with development of study documents including protocols and informed consent forms
Advising researchers and research teams on the regulatory review process
Tracking and facilitating the progress of new trials through the review process
Maintain working knowledge of current regulations and MGB IRB policies and guidance’s
Facilitate training for the research teams on changes to regulatory process or new regulatory requirements
Track protocol status and alert Investigators and management team of regulatory actions required

Qualification

Regulatory complianceICH GCPIND/IDE submissionsIRB submissionsClinicalTrial.govProtocol developmentTraining facilitationAdvising researchersTracking protocol status

Required

The preparation and submission of protocols to the IRB
Assists with development of study documents including protocols and informed consent forms
Advising researchers and research teams on the regulatory review process
Tracking and facilitating the progress of new trials through the review process
Maintain working knowledge of current regulations and MGB IRB policies and guidance's
Facilitate training for the research teams on changes to regulatory process or new regulatory requirements
Track protocol status and alert Investigators and management team of regulatory actions required

Benefits

Comprehensive benefits
Career advancement opportunities
Differentials
Premiums and bonuses as applicable
Recognition programs designed to celebrate your contributions and support your professional growth

Company

Mass General Brigham

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Mass General Brigham specializes in providing medical treatments and health diagnostics services.
dateFounded in 1994
location
Somerville, Massachusetts, USA
people-size10001+ employees
web-link
https://www.massgeneralbrigham.org

H1B Sponsorship

Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)

Funding

Current Stage
Late Stage

Leadership Team

E
Erin Flanigan
SVP, Human Resources, Community, Specialty Hospital Division
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O’Neil A. Britton
Chief Integration Officer, Executive Vice President
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Recent News

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Company data provided by crunchbase